EP3378507B1 - Injektionsvorrichtung mit einer nadelkanüle - Google Patents

Injektionsvorrichtung mit einer nadelkanüle Download PDF

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Publication number
EP3378507B1
EP3378507B1 EP18161793.7A EP18161793A EP3378507B1 EP 3378507 B1 EP3378507 B1 EP 3378507B1 EP 18161793 A EP18161793 A EP 18161793A EP 3378507 B1 EP3378507 B1 EP 3378507B1
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EP
European Patent Office
Prior art keywords
reservoir
injection device
needle cannula
cartridge
drug
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP18161793.7A
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English (en)
French (fr)
Other versions
EP3378507A1 (de
Inventor
Henrik Bengtsson
Lars Eilertsen
Casper Bo JENSEN
Frederik Kaae KIRK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
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Novo Nordisk AS
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Publication of EP3378507A1 publication Critical patent/EP3378507A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/2474—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with movable piercing means, e.g. ampoule remains fixed or steady
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3114—Filling or refilling
    • A61M2005/3115—Filling or refilling spring-assisted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3121—Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body

Definitions

  • the invention relates to an injection device such as an injection pen preferably in combination with a needle cannula.
  • the invention especially relates to such injection device wherein the same needle cannula is used for multiple successive injections and automatically cleaned between injections. Further, the invention relates to a method of preparing such injection device.
  • Shielded injection needle assemblies are known from e.g. WO 2008/077706 and US 5,292,314 .
  • a syringe having a manually operational telescopic shield is disclosed in EP 252,644 (figure 11-13).
  • a variable quantum of the drug contained in the syringe is ejected into a purging chamber forming the telescopic shield.
  • the user Prior to purging the syringe, the user must manually manipulate the telescopic shield into the correct position.
  • the user determines the volume ejected into the chamber of the shield.
  • Injection devices having an injection needle for repetitive use is disclosed in US 3,354,881 and US 4,416,663 .
  • These injection devices for repetitive use have a telescopic movable shield which covers the tip of needle cannula between injections.
  • the telescopic shield is pushed to its initial covering position by resilient means, which in US 4,416,663 is identified as being a spring.
  • the telescopic shield is provided with a reservoir containing a cleaning agent for cleaning the tip of the needle cannula between injections.
  • the cleaning agent is in both US 3,354,881 and US 4,416,663 referred to as a sterilizing fluid.
  • the sterilizing fluid can flow through the lumen of the needle cannula and into the interior of the cartridge and thus be mixed with the pharmaceutical liquid drug contained in the cartridge and thus contaminate the drug.
  • the sterilizing fluid that has flown into the cartridge is injected into the body of the user together with the pharmaceutical liquid drug of the cartridge.
  • the present invention relates to an injection device comprising the following details:
  • the telescopic movable needle covering shield is axially and telescopic movable in relation to the needle cannula between a first position and a second position.
  • the first and the second position being defined as;
  • the liquid in the cleaning reservoir of the shield contains the same preservatives as present in the pharmaceutical preservative containing liquid drug inside the cartridge.
  • a backflow of liquid through the lumen of the needle cannula from the reservoir of the telescopic shield and back into the chamber of the cartridge will not contaminate the liquid drug inside the cartridge as the same preservatives are present in both liquids.
  • the backflow will thus only very marginally raise the concentration of preservatives inside the chamber of the cartridge.
  • the volume of liquid in the reservoir of the telescopic shield is predetermined by the manufacture of the injection device and is preferably predetermined such that the tip of the needle cannula is fully submerged in the liquid between subsequent injections. This implies that the level to which the reservoir of the shield is filled must be sufficient to maintain at least the tip of the needle cannula submerged in the liquid in all situations.
  • the injection device can be any kind of pre-filled injection device.
  • the drive mechanism of the injection device can be either manual or spring-loaded.
  • manual is meant that the user delivers the force needed to press the liquid drug out of the cartridge
  • spring-loaded is meant that a spring, compression or torque, is provided in the injection and utilized, fully or partly, to press the liquid drug out through the lumen of the attached needle cannula.
  • the liquid in the reservoir of the telescopic shield is either phenol or metacresol or any combination thereof.
  • the preservatives can also be provided inside the reservoir of the telescopic shield in a solution of sterile injectable water.
  • the pharmaceutical preservative containing liquid drug in the injection device is a blood sugar regulating drug such as insulin, insulin analogue, GLP-1 or GLP-2.
  • the pharmaceutical preservative containing liquid drug could be a growth hormone.
  • the pharmaceutical preservative containing liquid drug could in an example be any commercially available liquid drug from the company Novo Nordisk A/S, e.g., NovoRapid®, NovoLog®, Levemir®, NovoMix®, Tresiba®, Ryzodeg®, Xultophy®, Victoza®, Saxenda® or Norditropin®, which all contains a preservative maintaining the liquid drug biostatic.
  • Novo Nordisk A/S e.g., NovoRapid®, NovoLog®, Levemir®, NovoMix®, Tresiba®, Ryzodeg®, Xultophy®, Victoza®, Saxenda® or Norditropin®, which all contains a preservative maintaining the liquid drug biostatic.
  • the needle cannula is permanently secured to the injection device.
  • the needle cannula can be secured in a hub by gluing, welding or the like.
  • the hub is then either permanently secured to the injection device, or provided with connecting means for detachable connecting the hub to the injection device.
  • the telescopic shield could be provided in conjunction with the hub to form a part of the needle assembly.
  • the reservoir of the telescopic shield is made as a through-going opening in the telescopic shield which distally is covered by a distal membrane and proximally covered by a proximal membrane.
  • membranes or septums are preferably made from a rubber composition as known from standard septums generally used in cartridges.
  • one of these membranes or septums and preferably the proximal septum of the reservoir could be movable in relation to the telescopic shield. This movement of the proximal septum is preferably in a proximal direction thus allowing the reservoir to be filled.
  • a carved-out portion in one or both of the septums is preferred such that the lumen of the needle cannula is not covered by the septum material in the initial position.
  • a reservoir is so to speak formed even in the abut situation such that the liquid pharmaceutical drug has a space to flow into when an initial quantum is ejected into the reservoir.
  • the filling of the reservoir is preferably done fully automatically and preferably by automatically moving the proximal septum in a proximal direction such that a vacuum is created inside the so expanding reservoir of the telescopic shield.
  • automatically means that the injection device is provided with means which generates the movement of the proximal septum.
  • the means generating this proximal movement is preferably resilient means such as spring or like element.
  • the proximal septum can in one particular embodiment be moved axially in the proximal direction by a pull spring which is e.g. released upon first use of the injection device.
  • the axial movement of the proximal septum and thus the vacuum created and the filling volume of the reservoir in the telescopic shield is determined by the manufacture of the injection device. It can be inherent in the force of the spring or various stops can be provided limiting the distance the proximal septum can move. In any way, the volume of liquid filled into the reservoir is solely determined by the manufacture of the injection device such that the injection device is delivered to the user with this predetermination being inherent in the injection device. The user thus only has to take the injection device into use following the instructions from the manufacturer where after, the reservoir will be automatically filled with the predetermined volume.
  • the proximal septum is preferably secured to an axial movable element which moves axially under influence of the second spring.
  • the movable element preferably moves proximally from a locked position to a position engaging the telescopic shield when a user operates a release mechanism which again can be automatically released first time a user sets a dose.
  • the injection device automatically ejects a predetermined volume of the pharmaceutical preservative containing liquid drug into the reservoir upon first use of the injection device.
  • the cap of the injection device can be coupled to a mechanism which automatically slides the cartridge proximally such that the rubber piston inside the cartridge is relatively moved to press out a predetermined volume.
  • This ejection mechanism could e.g. be coupled to the cap such that it is activated upon rotation of the cap.
  • the disclosure further includes a method of preparing the injection device prior to performing a series of injections i.e. the method is preferably executed when a new injection device is taken into use.
  • the injection device is preferably a pre-filled injection device which is only taken into use once and discarded when the cartridge is empty after a series of injections.
  • the method according to the invention therefore comprises of at least the following two steps:
  • the user must first secure that the tip of the needle cannula is inside the reservoir of the telescopic shield where after the release mechanism must be activated such that the predetermined volume is automatically transferred from the compartment of the cartridge and into the reservoir of the telescopic shield.
  • the release mechanism can be a movable element that the user must physically remove in order to activate the release or it can be integrated with the dose setting mechanism such that it is released first time the user sets a dose to be injected.
  • the volume automatically filled into the reservoir is determined by the manufacture of the injection device. It can be decided by the size of the vacuum generated which again can be a result of the spring force of the spring used to generate the vacuum. Alternatively it can be one or more physical stops provided in the injection device; stops which e.g. limits the axial movement of the proximal septum.
  • This method is in a further embodiment performed by releasing the movable element such that the second spring drives the movable element and the proximal septum in the proximal direction thereby creating a vacuum inside the reservoir.
  • this vacuum grows and the pharmaceutical preservative containing liquid drug is automatically sucked through the lumen on the needle cannula from the chamber of cartridge and into the reservoir of the telescopic shield.
  • injection pen is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.
  • needle Cannula is used to describe the actual conduit performing the penetration of the skin during injection.
  • a needle cannula is usually made from a metallic material such as e.g. stainless steel and connected to a hub to form a complete injection needle also often referred to as a "needle assembly".
  • a needle cannula could however also be made from a polymeric material or a glass material.
  • the hub also carries the connecting means for connecting the needle assembly to an injection apparatus and is usually moulded from a suitable thermoplastic material.
  • the "connection means” could as examples be a luer coupling, a bayonet coupling, a threaded connection or any combination thereof e.g. a combination as described in EP 1,536,854 .
  • Needle unit is used to describe one single needle assembly carried in a container.
  • Such container usually has a closed distal end and an open proximal end which is sealed by a removable seal.
  • the interior of such container is usually sterile such that the needle assembly is ready-to-use.
  • Needle units specially designed for pen injections systems are defined in ISO standard No. 11608, part 2, and are often referred to as "pen needles". Pen needles have a front part for penetrating into the user and a back part for penetrating into the cartridge containing the drug.
  • drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • Representative drugs includes pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
  • Preservative containing liquid drug is meant to encompass any flowable drug containing any amount of a preservative. In one example the preservative could be a phenol or a metacresol or any combination thereof. However, the wording preservative containing should not be limited to only these substances but should indeed mean any combination of a flowable drug and a preservative.
  • Cartridge is the term used to describe the container containing the drug. Cartridges are usually made from glass but could also be moulded from any suitable polymer.
  • a cartridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the "septum" which can be pierced e.g. by the non-patient end of a needle cannula.
  • Such septum is usually self-sealing which means that the opening created during penetration seals automatically by the inherent resiliency once the needle cannula is removed from the septum.
  • the opposite end is typically closed by a plunger or piston made from rubber or a suitable polymer. The plunger or piston can be slidable moved inside the cartridge. The space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger decreased the volume of the space holding the drug.
  • any kind of container - rigid or flexible - can be used to contain the drug.
  • Pre-filled injection device an injection device in which the cartridge containing the liquid drug is permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device. Once the pre-filled amount of liquid drug in the cartridge is used, the user normally discards the entire injection device. This is in opposition to a "Durable" injection device in which the user can himself change the cartridge containing the liquid drug whenever it is empty.
  • Pre-filled injection devices are usually sold in packages containing more than one injection device whereas durable injection devices are usually sold one at a time. When using pre-filled injection devices an average user might require as many as 50 to 100 injection devices per year whereas when using durable injection devices one single injection device could last for several years, however, the average user would require 50 to 100 new cartridges per year.
  • distal end in the appended figures is meant to refer to the tip 13 of the needle cannula 10 actually penetrating the skin of the user whereas the term “proximal end” is meant to refer to the opposite end pointing away from the user during injection and penetrating into the cartridge 20.
  • Figure 1 to 3 discloses the first embodiment in which an injection device carries a needle cannula 10.
  • the needle cannula 10 is in the depicted embodiment secured in a hub 15 which is removable connected to a housing 1 of the injection device by a thread 16.
  • the needle cannula 10 could be secured to the housing 1 in many different ways.
  • the needle cannula 10 could e.g. be formed permanently attached to the housing 1.
  • the needle cannula 10 has a front part 11 provided with a grinded tip 13 for easy piercing of the skin of a user and a back part 12 for penetrating into a chamber 21 of a cartridge 20.
  • the opposite cannula end could also be grinded, and the two ends are connected through a lumen 14.
  • the housing 1 is provided with a telescopic shield 30 which is urged in the distal direction by a first resilient element such as a first spring 40 such that the telescopic shield 30 conceals the tip 13 of the needle cannula 10 in a non-use situation i.e. when not injecting.
  • a first resilient element such as a first spring 40
  • the telescopic shield 30 is further provided with a reservoir 31 which in the disclosed embodiment is depicted as a cylindrical through-going opening which distally is sealed by a distal septum 32 and proximally is sealed by a proximal septum 33 such that the through-going opening forms the reservoir 31.
  • a pull spring 35 is encompassed between, and connected to, the proximal septum 33 and a wall 36 which again is secured to the telescopic shield 30.
  • the wall 36 could also be moulded as an integral part of the telescopic shield 30. This wall 36 together with the proximal septum 33 also supports and guides the needle cannula 10 thus preventing the front part 11 of the needle cannula 10 from bending when passing through the distal septum 32.
  • the injection device is depicted with the telescopic shield 30 positioned in the first position.
  • the telescopic shield 30 is urged in the distal direction by the spring 40 and the tip 13 of the needle cannula 10 is located inside the reservoir 31 (represented by the carved-out portion 34).
  • the pull spring 33 is in figure 1 depicted in its cocked position where it is held stretched out by a not-shown release mechanism.
  • this release mechanism is released, preferably by the user, the pull spring 36 pulls the proximal septum 33 in a proximal direction as disclosed in figure 2 .
  • This movement creates a vacuum inside the reservoir 31, which vacuum moves a part of the pharmaceutical preservative containing liquid drug from the chamber 21 of the cartridge 20 to the reservoir 31via the lumen 14 of the needle cannula 10.
  • the proximal septum 33 could be in a permanent position thus defining the reservoir 31 with a fixed volume.
  • the drive mechanism of the injection device could be set to inject a predetermined amount of pharmaceutical preservative containing liquid drug into the reservoir 31 the first time the injection device is taken into use. It would then be preferred if one of the septums 32, 33 were provided with a venting area through which the air trapped in the reservoir 31 could escape during filling of the reservoir 31.
  • the tip 13 of the needle cannula 10 is in figure 2 submerged into a quantum of the pharmaceutical liquid drug and since a pharmaceutical liquid drug usually contains preservative substances, these preservatives will clean the tip 13 of the needle cannula 10 whenever the tip 13 is inside the reservoir 31.
  • the telescopic shield 30 When a user presses the injection device against the skin as indicated by arrows "A" in figure 3 , the telescopic shield 30 is pushed in the proximal direction into its second position against the bias of the first spring 40.
  • the front part 11 of the needle cannula 10 and especially the tip 13 of the needle cannula 10 thus penetrates through the distal septum 32 and an injection can be performed either manually or automatically.
  • the telescopic shield 30 is urged into the first position by the first spring 40 which makes the tip 13 of the needle cannula 10 once again enter into its submerged position inside the reservoir 31 as depicted in figure 2 .
  • Figure 4 discloses the injection device with the telescopic shield 30 in the first position.
  • the needle cannula 10 is mounted in a telescopic movable hub 15 and the telescopic shield 30 is urged in a distal direction by the first spring 40.
  • the tip 13 of the needle cannula 10 is located inside the reservoir 31 which in figure 4 is limited to the carved-out portion 34.
  • this carved-out portion 34 is formed in the proximal septum 33 but it could easily be provided in the distal septum 32 or in both septums 32, 33.
  • the proximal septum 33 is carried by a movable element 50 which is urged in the proximal direction by a second spring 45.
  • a not disclosed release mechanism secures the movable element 50 and prevents it from moving proximally before the user actually activates the injection device.
  • This release mechanism could in a simple form e.g. be a tab (indicated as "T” in figure 4 ) that the user must remove before first use of the injection device.
  • a similar tab could be provided in the first embodiment to secure the pull spring 35 in its stretched condition.
  • the release mechanism could alternatively be coupled to the dose dial, such that once a dose is being dialled, the movable element 50 is released and moves automatically in the proximal direction under the influence of the second spring 45. This proximal movement presses the hub 15 over the distal end of the cartridge 20 such that the back part 12 of the needle cannula 10 enters into liquid communication with the chamber 21 of the cartridge 20.
  • the coupling between the hub 15 and the cartridge 20 is in the depicted embodiment designed such that the back part 12 of the needle cannula 10 thereafter remains in this liquid communicating position as will be explained.
  • Figure 5 discloses the movable element 50 in its proximal position in which a radial ridge 51 provided on the movable element 50 is locked in a similar groove 36 provided internally in the telescopic shield 30 such that the movable element 50 thereafter moves telescopic together with the telescopic shield 30.
  • both the telescopic shield 30 and the movable element 50 retracts together thus maintaining the reservoir 31 with the same constant volume.
  • the user removes the telescopic shield 30 from his or hers skin where after the first spring 40 urges the telescopic shield 30 and the movable element 50 distally such that the tip 13 of the needle cannula 10 re-enters into the reservoir 31 where it is maintained submerged in the cleaning liquid until the next injection.
  • FIG. 8-9 Yet another embodiment is disclosed in figure 8-9 in which the same numbering of the various elements have been maintained.
  • the pharmaceutical liquid preservative containing drug is pressed out through the lumen 14 of the needle cannula 10 by moving a rubber piston 25 forward inside the cartridge 20 thereby decreasing the volume of the chamber 21.
  • a piston rod 26 is driven in the distal direction by a not-shown drive mechanism.
  • the distal end of the injection device is located inside a protective cap 2 as is common with injection devices.
  • This cap 2 is coupled to the injection device such that when a user rotates the cap 2, the distal part of the injection device is forced to move proximally.
  • the rubber piston 25 remains in its previous position due to the piston rod 26 which is locked against any proximal movement by the drive mechanism.
  • the injection device moves the distance "X" in the proximal direction as depicted in figure 9 .
  • This movement also moves the cartridge axially a distance "Y” in relation to the rubber piston 25 thereby ejecting a predetermined amount of the pharmaceutical liquid preservative containing drug into the reservoir 31.
  • liquid pharmaceutical drug contained in the chamber 21 of the cartridge 20 and in the reservoir 31 of the telescopic shield 30 could be NovoLog®, which is manufactured and sold by Novo Nordisk A/S.
  • NovoLog® is a sterile, aqueous, clear, and colourless solution that contains:
  • NovoLog has a pH of 7.2-7.6 and Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH.
  • the preservatives are simultaneously present both in the chamber 21 of the cartridge 20 and in the reservoir 31 of the telescopic shield 30. Since the liquid in the chamber 21 and in the reservoir 31 is the same pharmaceutical preservative containing liquid drug, the exchange of liquid through the lumen 14 of the needle cannula 10 has no influence on the pharmaceutical preservative containing liquid drug to be injected as only the identical same pharmaceutical preservative containing liquid drug is present in the chamber 21 of the cartridge 20 and in the reservoir 31 of the telescopic shield 30.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (4)

  1. Vorbefüllte Injektionsvorrichtung zum Injizieren eines pharmazeutischen flüssigen Medikaments, das ein Konservierungsmittel enthält, umfassend:
    - ein Gehäuse (1), das eine Patrone (20) trägt, die dauerhaft in die Injektionsvorrichtung eingebettet ist und eine Innenkammer (21) aufweist, die das zu injizierende flüssige Medikament enthält, welches das pharmazeutische Konservierungsmittel enthä lt,
    - eine Nadelkanüle (10), die dauerhaft an der Injektionsvorrichtung befestigt und für Mehrfachinjektionen verwendbar ist und einen vorderen Teil (11) mit einer Spitze (13) und einen hinteren Teil (12) aufweist, wobei der hintere Teil (12) derart angepasst ist, dass er in Flüssigkeitsverbindung mit der Innenkammer (21) der Patrone (20) ist, und
    - einen Teleskopnadelabdeckschild (30), der distal mit einem Vorratsbehälter (31) versehen ist, welcher ein vorbestimmtes Volumen einer Flüssigkeit zur Reinigung von mindestens der Spitze (13) der Nadelkanüle (10) zwischen aufeinanderfolgenden Injektionen einschließt, und wobei der Teleskopnadelabdeckschild (30) durch ein erstes elastisches Element (40) distal in eine erste Position gedrängt wird und während der Injektion proximal gegen die Vorspannung des ersten elastischen Elements (40) in eine zweite Position bewegt wird;
    - wobei die erste Position eine Position ist, in der sich die Spitze (13) des vorderen Teils (11) der Nadelkanüle (10) innerhalb des Vorratsbehälters (31) befindet, und
    - die zweite Position eine Position ist, in der sich die Spitze (13) des vorderen Teils (11) der Nadelkanüle (10) außerhalb des Vorratsbehälters (31) und distal zu dem Vorratsbehälter (31) befindet,
    und wobei das vorbestimmte Flüssigkeitsvolumen, das in dem Vorratsbehälter (31) des teleskopischen Nadelabdeckschilds (30) eingeschlossen ist, entweder Phenol oder Metakresol oder eine beliebige Kombination davon ist, welches das gleiche Konservierungsmittel ist, wie es in dem dem flüssigen Medikament, welches pharmazeutische Konservierungsmittel enthält, vorhanden ist, das in der Kammer (21) der Patrone (20) enthalten ist.
  2. Medikamentenabgabevorrichtung nach Anspruch 1, wobei das flüssige Medikament, welches das pharmazeutische Konservierungsmittel enthält, ein blutzuckerregulierendes Medikament wie Insulin, ein Insulinanalogon, GLP-1 oder GLP-2 ist.
  3. Medikamentenabgabevorrichtung nach einem der Ansprüche 1 oder 2, wobei die Nadelkanüle (10) in einer Nabe (15) befestigt ist, die dauerhaft an der Injektionsvorrichtung befestigt ist.
  4. Medikamentenabgabevorrichtung nach einem der vorstehenden Ansprüche, wobei der Vorratsbehälter (31) des Teleskopschilds (30) distal mit einem distalen Septum (32) und proximal mit einem proximalen Septum (33) versehen ist.
EP18161793.7A 2013-10-31 2014-10-10 Injektionsvorrichtung mit einer nadelkanüle Active EP3378507B1 (de)

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EP13191052 2013-10-31
US201361899413P 2013-11-04 2013-11-04
EP14781911.4A EP3062836B1 (de) 2013-10-31 2014-10-10 Injektionsvorrichtung mit einer nadelkanüle
PCT/EP2014/071746 WO2015062845A1 (en) 2013-10-31 2014-10-10 Injection device with a needle cannula

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EP14781911.4A Division EP3062836B1 (de) 2013-10-31 2014-10-10 Injektionsvorrichtung mit einer nadelkanüle
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JP (1) JP6483676B2 (de)
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ES (1) ES2674227T3 (de)
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TR201808189T4 (tr) 2018-07-23
PL3062836T3 (pl) 2018-08-31
US10335535B2 (en) 2019-07-02
ES2674227T3 (es) 2018-06-28
US20160271319A1 (en) 2016-09-22
JP6483676B2 (ja) 2019-03-13
CN105658256B (zh) 2019-06-18
EP3062836B1 (de) 2018-04-25
WO2015062845A1 (en) 2015-05-07
CN105658256A (zh) 2016-06-08
EP3062836A1 (de) 2016-09-07
JP2016538916A (ja) 2016-12-15
EP3378507A1 (de) 2018-09-26
DK3062836T3 (en) 2018-06-25
HUE039246T2 (hu) 2018-12-28

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